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Filtering on: "topics business skills"

Showing 1 – 25  of 93

8 Networking Tips for Regulatory Convergence Attendees By Zachary Brousseau - Published 24 August 2017

RAPS’ Regulatory Convergence offers attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. To make the best impression you can, and hopefully build long-lasting, mutually beneficial relationships, there are a few networking basics you should keep in mind.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business Skills

Tags: Regulatory Convergence, conference, networking

Organizational Culture and Memory in Managing Risk in the Medical Device Industry By Darin Oppenheimer, DRSc, Suraj Ramachandran, MS, RAC - Published 15 August 2017

This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."

Categories: Features, US, FDA, Business Skills, Medical Devices

Tags: Risk Management, Organizational Culture

Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August By Gloria Hall - Published 01 August 2017

Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.

Categories: Features, Career Development

Tags: Features, Regulatory Focus

A View From the Top: An Interview with CRI President Jennifer Kerr, RAC By Mary Faderan, PhD, RAC - Published 31 July 2017

This article is based on an interview with Cook Research Incorporated (CRI) president Jennifer Kerr and covers a wide range of topics from her education, to how she became interested in regulatory, to her experiences in clinical affairs and her responsibilities at CRI.

Categories: Features, Career Development, Communication

Tags: Interview, RAC

Resources and Training for Regulatory Professionals By Sofia Campos Silva, MSc, PharmD - Published 27 July 2017

This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.

Categories: Features, Business and Leadership, Career Development, Regulatory intelligence

Ten Secrets to Regulatory Success By Jody J. Savage, MS, MBA - Published 20 July 2017

This article highlights "10 secrets to success" for regulatory professionals that may not be taught in formal regulatory affairs training programs, but practices the author learned "on the job." It includes suggestions for developing regulatory submissions and the importance of good writing, doing your "homework" and systematizing work procedures.

Categories: Features, Career Development, Communication

Careers in Regulatory Advertising and Promotion By Dana Huettenmoser, PharmD - Published 19 July 2017

This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.

Categories: Features, Advertising and Promotion, Career Development

Regulatory Career Progression By Kamila Kawiak, Kavita Patel - Published 17 July 2017

This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.

Categories: Features, Business and Leadership, Career Development, Career Search

Tags: Career Development, Regulatory Profession

7 Things to Love About the Regulatory Convergence By Zachary Brousseau - Published 06 July 2017

Here are seven things to love about the Regulatory Convergence, the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space and RAPS’ signature event.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose

New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Senate Confirms Gottlieb as Next FDA Commissioner By Zachary Brennan - Published 09 May 2017

The Senate on Tuesday afternoon voted along party lines to confirm Dr. Scott Gottlieb as the next US Food and Drug Administration (FDA) commissioner.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Drugs, Government affairs

Tags: Scott Gottlieb, FDA commissioner, new FDA commissioner

RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation By Zachary Brousseau - Published 07 April 2017

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS' Executive Development Program was designed to help them hone their business, management and leadership skills.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Education, Career Development

Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April By Gloria Hall - Published 05 April 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.

Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices

Tags: Features, Regulatory Focus

Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts By Zachary Brennan - Published 27 March 2017

With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change.

Categories: News, US, Business Skills, Drugs, Government affairs

Tags: drug company profits, drug prices, R&D spending on pharmaceuticals

The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues By Mary Ellen Cosenza, PhD, RAC - Published 16 March 2017

This article discusses why regulatory and business functions need to work together to ensure success in label development, launch, promotion and lifecycle management strategy and regulatory intelligence and provides successful partnership examples.

Categories: Features, Business Skills, Communication

Strategies and Tactics to Successfully Outsource Regulatory Work By Bill Snyder - Published 15 March 2017

This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.

Categories: Features, US, Business Skills

Tags: Outsourcing, Performance Metrics

Why Regulatory Professionals Need Business Training By William C. Putnam, PhD, RAC - Published 02 March 2017

Because regulatory decisions have a direct impact on business outcomes, regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

Is Regulatory Affairs Certification Right for You? By Zachary Brousseau - Published 06 February 2017

The decision to pursue Regulatory Affairs Certification (RAC) is a personal one with many variables to consider—from the amount of regulatory experience you have and the potential value of having the credential to how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.

Categories: HTML, Articles, RAC, Under RAPS, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification

Unifying Best Practices for Managing Regulatory Processes: Part 3 By Jim Reilly - Published 21 December 2016

This article highlights the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape as seen in the eyes of life sciences leaders who report their struggles in uniting disparate processes, systems and data.

Categories: Features, Business Skills, Project management, Regulatory strategy

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

The Evolving Role of the Regulatory Professional By Pallavi Trivedi MPH, RAC, Sharad Trivedi, MS, PMP - Published 28 October 2016

This article discusses the multifaceted role of regulatory professionals who must guide internal company functions from product formulation and analytical development, to manufacturing, supply chain, quality control, clinical and non-clinical science and statistics. The role includes understanding the changing regulatory environment, interpreting laws and regulations and generating relevant data to support compliance.

Categories: Features, Business Skills

Entering the China Market: Go-to-Market Strategies - Part 2 By Landon G. Lack - Published 23 August 2016

This is the second of a two-part series looking at best practices for medical device companies planning to enter the China market.

Categories: Features, China, Business Skills, Medical Devices

Reflections on Mergers and Acquisitions in the Healthcare Product Industry By Mark Gordon, MS, RAC, FRAPS, Sue James, RAC, FRAPS, Steven Knapp, MS, PharmD, Rosanne Yetemian, PhD, MSRS, RAC, Daniel G. Mannix, PhD - Published 18 August 2016

This article outlines critical process points, seven reflections from recent Merger and Acquisition (M&A) experiences and suggests best practices for optimizing M&A due diligence from several perspectives. In addition, the article offers insight and guidance on how to act, what to look for in due diligence exercises and what areas to further explore as one partakes in due diligence activities. The content was adapted from a session at the RAPS 2015 Regulatory Convergence in Baltimore, Maryland.

Categories: Features, Business and Leadership, Business Skills, Due Diligence

Tags: Mergers and Acquisitions, M&A, Due Diligence

RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role; Compensation Up By Zachary Brousseau - Published 17 August 2016

RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession.

Categories: HTML, Articles, Under RAPS, About the Profession, Career Development

Tags: Scope of Practice, compensation, salary, survey, 2016 Scope of Practice & Compensation Report

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process